(2 days)
Not Found
Not Found
No
The summary describes a vascular graft, a physical implant, and contains no mention of software, algorithms, or AI/ML terms.
Yes
The device is a vascular graft used to replace or repair diseased arteries, which directly treats a medical condition.
No
The provided text describes the Hemashield Platinum vascular grafts as devices for replacing or repairing arteries, indicating a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device described is a vascular graft, which is a physical implant, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the replacement or repair of arteries affected by disease. This is a surgical procedure performed directly on the patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or monitoring based on sample analysis.
- Using reagents or kits for testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hemashield Platinum vascular graft is a medical device used for surgical implantation, not for in vitro testing.
N/A
Intended Use / Indications for Use
The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Product codes (comma separated list FDA assigned to the subject device)
MAL
Device Description
The Hemashield Platinum grafts are different from the Hemashield Gold grafts only in the label claim for permeability.
The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence:
- Identical indications for use
- Identical labeling
- Identical manufacturing process flow
- Identical operating principle
- Incorporate identical materials
- Have the identical shelf-life (5 years)
- Are packaged and sterilized using identical packaging materials and processes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
APR 1 9 2002
Ko2/a13
Special 510(k) -- Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002
Section 5
Summary of Substantial Equivalence
| Summary of
Modifications | As shown previously in this submission, the Hemashield Platinum
grafts are different from the Hemashield Gold grafts only in the label
claim for permeability. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The modified vascular grafts have the following similarities to those
which previously received 510(k) concurrence:
• Identical indications for use
• Identical labeling
• Identical manufacturing process flow
• Identical operating principle
• Incorporate identical materials
• Have the identical shelf-life (5 years)
• Are packaged and sterilized using identical packaging materials
and processes
In summary, the Hemashield Platinum vascular grafts described in this
submission are equivalent to the predicate device. |
Continued on next page
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2002
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
K021213 Re:
Trade Name: Modification to Hemashield Platinum Woven/Microvel Double Velour Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular graft prosthesis of 6 millimeters and greater diameter. Regulatory Class: Class II (two) Product Code: MAL Dated: April 16, 2002 Received: April 17, 2002
Dear Ms. Bolton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for two based in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , aross provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Ms. Jennifer Bolton, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
hre
Donna Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) - Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002
Indications For Use
| 510(k)
Number
| (if known) | Unknown |
|---|---|
| Device | |
| Name: | Hemashield Platinum Woven Double Velour Vascular Grafts |
| Hemashield Platinum Microvel Double Velour Vascular Grafts | |
| Indications | |
| for Use | The Hemashield Platinum vascular grafts are indicated for use in the |
| replacement or repair of arteries affected with aneurysmal or occlusive | |
| disease. The prosthesis is also recommended for use in patients | |
| requiring systemic heparinization prior to, or during, surgery. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use_ (Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices 510(k) Number_ Koz Z/Z-(Z-12-12-12-12-12-12-12